LeMaitre AlboGraft Gebrauchsanweisung Seite 5

sterility has expired.
• The collagen-impregnated graft must never be resterilized.
• Grafts contaminated with blood during the preceding procedures must not be re-used or resterilized.
• The vascular grafts must be handled so as to avoid contact with extraneous particles which, if they
adhere to the graft wall, may generate emboli or undesirable interactions with the blood. Furthermore,
surgical gloves used to handle grafts should not contain powders, preservatives or lubricants.
• Avoid overstretching the graft; gently expand the graft to smooth the folds.
• Avoid damaging the graft when handling, use atraumatic clamps and appropriate instruments (e.g.
vascular clamps). Avoid using these instruments with undue force, otherwise the collagen coating or
fabric will be damaged.
• Atraumatic needles are recommended.
• Low temperature ophthalmic cautery (≤ 704° C/1300° F) is recommended for cutting woven grafts to
avoid fraying.
• AlboGraft Removable Spiral Reinforcement Prosthesis (ASC Models)*: Avoid clamping the graft on its
reinforced area.
• AlboGraft Removable Spiral Reinforcement Prosthesis (ASC Models)*: Gently remove the support spiral,
otherwise the collagen fi lm will be damaged.
• Care should be taken to ligate and/or cauterize lymphatics in the groin to minimize the occurrence of
seroma formation and lymphatic collection subsequent to aorto-femoral or femoropopliteal reconstruc-
tion.
• These prostheses should not be implanted in patients who exhibit sensitivity to polyester or materials of
bovine origin.
Re-sterilization/Repackaging
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility of the
re-processed device cannot be assured. Reuse of the device may lead to cross contamination, infection, or
patient death. The performance characteristics of the device may be compromised due to reprocessing or re-
sterilization since the device was only designed and tested for single use. The shelf life of the device is based
on single use only. If for any reason this device must be returned to LeMaitre Vascular, place it in its original
packaging and return it to the address listed on the box.
Conservation and Storage
The grafts must be kept in their original packaging until used. They must be kept in a dustfree and dry environ-
ment and at a temperature between 0° C /32°F and 30° C/ 86° F.
Safe Handling and Disposal
If serious medical incidents should arise during use of this medical device, users should notify both
LeMaitre Vascular and the Competent Authority of the country where the user is located.
This product contains no sharps, heavy metals or radioisotopes, and is not infectious or pathogenic. No
special requirements for disposal are evident. Please consult local regulations to verify proper disposal.
Packaging and Shipping of Explanted AlboGraft:
Return of the shipment to LeMaitre Vascular depends on 3 crucial questions:
1. Is the explant obtained from a patient with a known or presumed pathogenic condition at the
time of the explant?
2. Is the explant obtained from a patient that has a known treatment history that involves
therapeutic radionuclides within the last 6 months?
3. Has the clinician obtained consent from the patient for the sample to be returned to the
manufacturer for research purposes?
* Not available for sale in the United States or Canada.
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